SOP: Annual Evaluations of the Human Research Protection Program
1
NUMBER
DATE
AUTHOR
APPROVED BY
PAGE
HRP-010
2/6/2016
C. Bienstock
J. Silverstein
1 of 2
PURPOSE
1.1
2
This procedure establishes the process to conduct annual evaluations of the human research
protection program.
1.2 The process begins the first business day of each November.1
1.3 The process ends when all evaluations have been completed and communicated to those
evaluated.
REVISIONS FROM PREVIOUS VERSION
2.1
3
None
POLICY
3.1
3.2
4
The human research protection program is evaluated annually.
The subject outreach program for enhancing the understanding of subjects, prospective subjects,
and communities is accomplished by making the document “BROCHURE - Should I Take Part in
Research” available to the patient population.
RESPONSIBILITIES
4.1
5
PPHS staff ensure completion of these procedures.
PROCEDURE
5.1
5.2
5.3
5.4
5.5
1
Have the Organizational Official or designee evaluate the resources provided to the human
research protection program and make adjustments as part of the budgeting process.
Evaluate whether the number of IRBs is appropriate to the volume and types of research reviewed.
5.2.1 Provide a copy of the evaluation to the Organizational Official or designee.
5.2.2 If the number of IRBs is not appropriate to the volume and types of research reviewed,
work with the Organizational Official or designee to modify the IRB structure.
Have the IRB chair or IRB manager evaluate the knowledge, skills, and performance of each
regular and alternate IRB member.
5.3.1 Provide a copy of the evaluation to the Organizational Official or designee.
5.3.2 Provide a copy of the evaluation to each IRB member.
5.3.3 Send a copy of the “TEMPLATE LETTER: IRB Member Appreciation” to the IRB
member’s supervisor.
5.3.4 If needed, work with each IRB member to develop a plan to improve the individual’s
knowledge, skills, and performance.
Have the Organizational Official or designee evaluate the knowledge, skills, and performance of
each IRB chair.
5.4.1 Provide a copy of the evaluation to the Organizational Official or designee.
5.4.2 Provide a copy of the evaluation to each IRB chair.
5.4.3 If needed, work with each IRB chair to develop a plan to improve the individual’s
knowledge, skills, and performance.
Follow the Human Resources annual employee evaluation process to evaluate the knowledge,
skills, and performance of PPHS staff.
5.5.1 Provide a copy of the evaluation to the Organizational Official or designee.
5.5.2 Provide a copy of the evaluation to each IRB staff.
5.5.3 If needed, work with each IRB staff person to develop a plan to improve the individual’s
knowledge, skills, and performance.
Modify to coincide with the usual time for annual evaluation of personnel and resources.
SOP: Annual Evaluations of the Human Research Protection Program
NUMBER
DATE
AUTHOR
APPROVED BY
PAGE
HRP-010
2/6/2016
C. Bienstock
J. Silverstein
2 of 2
Complete the “WORKSHEET: IRB Composition” to evaluate whether the composition of the IRB
meets regulatory and organizational requirements.
5.6.1 Provide a copy of the evaluation to the Organizational Official.
5.6.2 If the composition of an IRB does not meet regulatory and organizational requirements,
work with the Organizational Official or designee to modify the IRB composition.
5.7 Evaluate the subject outreach plan.
5.7.1 Provide a copy of the evaluation to the Organizational Official or designee.
5.7.2 If the subject outreach program is not meeting organizational goals, work with the
Organizational Official or designee to modify the plan.
5.8 Check when the last time each IRB was registered. If more than 2 years, update the registration.2
5.9 Check when the last time the federalwide assurance (FWA) was updated or renewed. If more than
2 years, update/renew the FWA.3
MATERIALS
5.6
6
6.1
6.2
6.3
7
BROCHURE - Should I Take Part in Research
WORKSHEET: IRB Composition
TEMPLATE LETTER: IRB Member Appreciation
REFERENCES
7.1
2
None
See http://www.hhs.gov/ohrp/assurances/. Use the form at http://www.hhs.gov/ohrp/humansubjects/assurance/regirb.rtf
or use the Web site: http://ohrp.cit.nih.gov/efile/.
3
See http://www.hhs.gov/ohrp/humansubjects/assurance/renwfwa.htm. Use the domestic or international form or use
the Web site: http://ohrp.cit.nih.gov/efile/.